Evaluation of Phlebotomy as a Treatment for Non-alcoholic Fatty Liver Disease


The purpose of this study is to evaluate the use of phlebotomy (blood taking)as a treatment for patients with non-alcoholic fatty liver disease.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2011

Detailed Description

In this study phlebotomy will be evaluated as a therapy for non-alcoholic fatty liver disease (NAFLD), a common and important cause of liver disease. Phlebotomy has been used for many years in the treatment of disorders of iron overload such as hemochromatosis, where it is well tolerated and improves symptoms and survival. There is some evidence that it is also effective in treating NAFLD. However, previous studies have not evaluated whether phlebotomy improves liver biopsy findings. We will measure the severity disease in NAFLD patients prior to phlebotomy therapy and again at the end of treatment. This will allow us to accurately determine the benefit of this therapy in these patients.


  • Procedure: Phlebotomy
    • Phlebotomy involves the removal of blood (approximately 500mL) each week until body iron levels reach the low-normal level

Arms, Groups and Cohorts

  • Other: treatment
    • Iron depletion via phlebotomy

Clinical Trial Outcome Measures

Primary Measures

  • Severity of liver disease
    • Time Frame: 6 months after final treatment

Secondary Measures

  • Severity of metabolic disease
    • Time Frame: 6 months after final treatment

Participating in This Clinical Trial

Inclusion Criteria

  • Patients 18y or older
  • Diagnosis of Non-alcoholic Fatty Liver Disease

Exclusion Criteria

  • Unable or unwilling to provide informed consent
  • Alcohol consumption of >10g/day for women and >20g/day for men

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Western Ontario, Canada
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Melanie D Beaton, MD, Principal Investigator, University of Western Ontario, Canada

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